Epithod®616 COVID-19 Ag Test Kit
Manufactured by DxGen Corp., South Korea - www.dxgenco.com
Device identification number
1718
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
3 minutes
LOD
10000 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
A measured immunochromatic intensity is larger than cut-off value mainly due to non-specific binding
Fn
A measured immunochromatic intensity is lower than cut-off value mainly due to limit of sensitivity
Precision
not evaluated
Accuracy
100 % ((Antigen))
Reproducibility
not evaluated
Robustness
evaluated
Clinical Sensitivity
96 % ((Antigen))
Type of antigen
nucleoprotein
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements